Guide wire

Abstract

To ensure proper torque transmission. [Solution] The guide wire comprises a core shaft 60, a sensor, a first insulating layer 61 provided on the radially outer side of the core shaft 60, a conductor layer 62 provided on the radially outer surface of the first insulating layer 61 and electrically connected to the sensor, a second insulating layer 63 provided on the radially outer surface of the conductor layer 62, and a metal layer 64 provided on the radially outer side of the second insulating layer 63 and not electrically connected to the conductor layer 62.

Description

Technical Field

[0001] The present disclosure relates to a guide wire.

Background Art

[0002] When treating stenosis occurring in blood vessels such as coronary arteries surrounding the heart or treating a site where the inside of the blood vessel is blocked due to the progression of calcification, a guide wire for guiding treatment instruments such as balloon catheters is inserted into the blood vessel prior to these treatment instruments.

[0003] Patent Document 1 discloses a guide wire provided with a sensor for measuring physiological parameters in a patient's body. This guide wire has a structure in which a ribbon wire is embedded in an insulating layer coated on a core wire. [[ID=http: / / www.example.com / 18]]

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] For example, a guide wire in which a ribbon wire is embedded on a core wire has a smaller cross-sectional area that can be secured as a core wire compared to a general guide wire without a sensor. For this reason, the rigidity of the guide wire decreases, and the torque transmission property from the proximal end side to the distal end side of the guide wire decreases.

[0006] [[ID=http: / / www.example.com / 43]]On the other hand, for the purpose of ensuring rigidity, a method of arranging a ribbon wire inside a pipe-shaped core wire is also conceivable. In this method, since the bending resistance of the core wire decreases, there is a risk that the torque transmission property deteriorates due to kinking.

[0007] ] This disclosure is made based on the circumstances described above and provides a technology that can ensure appropriate torque transmission. [Means for solving the problem]

[0008] A guide wire relating to one viewpoint is a guide wire comprising: a core shaft; a sensor; a first insulating layer provided radially outside the core shaft; a conductor layer provided radially outside the first insulating layer and electrically connected to the sensor; a second insulating layer provided radially outside the conductor layer; and a metal layer provided radially outside the second insulating layer and not electrically connected to the conductor layer. [Brief explanation of the drawing]

[0009] [Figure 1] Figure 1 is a front view of the guide wire according to the first embodiment. [Figure 2] Figure 2 is a front view of the main body according to the first embodiment. [Figure 3] Figure 3 is a cross-sectional view of the large diameter portion according to the first embodiment. [Figure 4] Figure 4 is a cross-sectional view of the larger diameter portion of the comparative example. [Figure 5] Figure 5 is a front view of the main body according to the second embodiment. [Figure 6] Figure 6 is a cross-sectional view of the large diameter portion according to the second embodiment. [Figure 7] Figure 7 is a front view of the main body according to the third embodiment. [Figure 8] Figure 8 is a cross-sectional view of the large diameter portion according to the third embodiment. [Modes for carrying out the invention]

[0010] Guide wires according to several embodiments will be described with reference to the drawings. This disclosure is not limited to the embodiments shown in the drawings. The guide wires shown in each drawing are shown with example dimensions to facilitate understanding of the implementation, and the actual dimensions are not limited thereto. In this specification, “tip side” and “tip direction” mean the side and direction in which the tip of the guide wire is located. “Proximal side” and “proximal direction” mean the side and direction opposite to “tip side” and “tip direction”. “Tip” refers to the tip end of any member or part, and “proximal end” refers to the proximal end of any member or part.

[0011] <First Embodiment> Figure 1 is a front view of the guide wire according to the first embodiment. Figure 2 is a front view of the main body according to the first embodiment.

[0012] The guide wire 1 comprises a main body 10, a tip 20, a coil body 21, a coil body 22, a sensor connection part 30, and a sensor 40.

[0013] The main body 10 is a long member that extends from the base end to the tip end of the guide wire 1. As shown in Figure 2, the main body 10 includes a large diameter portion 11, a tapered portion 12, a small diameter portion 13, and an external connection portion 14. The large diameter portion 11 is, for example, cylindrical in shape. The tapered portion 12 is the part that smoothly connects the tip of the large diameter portion 11 and the base end of the small diameter portion 13. The outer diameter of the tapered portion 12 is formed to gradually decrease from the outer diameter of the large diameter portion 11 to the outer diameter of the small diameter portion 13. The tapered portion 12 has a conductor layer (not shown) that is electrically connected to the conductor layer 62 of the large diameter portion 11, which will be described later.

[0014] The narrow-diameter section 13 is connected to the tip side of the tapered section 12. The outer diameter of the narrow-diameter section 13 is smaller than the outer diameter of the wide-diameter section 11. The coil body 21, the sensor connection section 30, and the coil body 22 are connected to the outer circumference of the narrow-diameter section 13. The narrow-diameter section 13 has a conductive layer that electrically connects the conductive layer of the tapered section 12 and the electrode of the sensor connection section 30.

[0015] The external connection part 14 is connected to the proximal end side of the large-diameter part 11. The external connection part 14 has, for example, a plurality of ring-shaped electrodes 50. The electrode 50 is electrically connected to the sensor 40 through the conductor layer 62 of the large-diameter part 11, and is an electrode for electrically connecting the sensor 40 and an external device (not shown).

[0016] The sensor 40 measures parameters such as the pressure, temperature, and flow rate of the body tissue into which the guide wire 1 is inserted. The sensor 40 outputs the measured signal to the electrode 50 of the external connection part 14 through the sensor connection part 30, the conductor layer inside the main body part 10, etc.

[0017] The sensor connection part 30 is provided in the small-diameter part 13 between the coil body 21 and the coil body 22. The sensor connection part 30 can physically connect the sensor 40. The sensor connection part 30 has an electrode for electrically connecting the sensor 40 and the conductor layer inside the main body part 10.

[0018] The coil body 21 is provided so as to cover the outer periphery of the distal end side of the main body part 10. The coil body 21 is a hollow cylindrical coil in which one or more strands are spirally wound around the main body part 10. The coil body 22 is provided so as to cover the outer periphery of the main body part 10 on the side more distal than the coil body 21. The coil body 22 is a hollow cylindrical coil in which one or more strands are spirally wound around the main body part 10.

[0019] The strands of the coil body 21 and the coil body 22 may be single wires of one or more strands, or may be stranded wires of one or more strands. The material of the strand may be, for example, stainless steel such as SUS316, superelastic alloy such as Ni-Ti alloy, radiation-impermeable metal such as platinum, tungsten, etc.

[0020] The tip chip 20 is provided at the tip of the guide wire 1. The tip chip 20 has a convex shape such as a hemispherical shape toward the tip side. The tip chip 20 joins the tip of the thin-diameter portion 13 of the main body 10 and the tip of the coil body 22. The material of the tip chip 20 may be, for example, brazing materials such as aluminum alloy brazing, silver brazing, gold brazing, etc., metal solder such as Ag-Sn alloy, Au-Sn alloy, adhesives such as epoxy adhesives, etc.

[0021] FIG. 3 is a cross-sectional view of the large-diameter portion according to the first embodiment. FIG. 3 is a cross-sectional view of the guide wire 1 in the large-diameter portion 11, that is, a cross-sectional view in a plane perpendicular to the longitudinal direction of the guide wire 1.

[0022] The large-diameter portion 11 includes a core shaft 60, a first insulating layer 61, a conductor layer 62, a second insulating layer 63, and a metal layer 64. In this embodiment, the large-diameter portion 11 is integrated by joining each layer of the core shaft 60, the first insulating layer 61, the conductor layer 62, the second insulating layer 63, and the metal layer 64. Thereby, the torsional rigidity of the large-diameter portion 11 can be improved.

[0023] The core shaft 60 is a long shaft extending from the proximal end to the distal end of the guide wire 1. In this embodiment, the core shaft 60 has a substantially cylindrical shape. The material of the core shaft 60 may be, for example, metals such as stainless steel such as SUS304, Ni-Ti alloy, Co-Cr alloy, etc. The total length of the core shaft 60 may be, for example, 1,800 to 3,000 mm. The diameter of the core shaft 60 may be, for example, 0.06 mm to 0.33 mm.

[0024] The first insulating layer 61 is provided so as to be bonded to the outer circumference of the core shaft 60. In this embodiment, the first insulating layer 61 is provided so as to cover the entire outer circumference of the core shaft 60. The first insulating layer 61 has at least electrical insulating properties. For example, materials that can be used for the first insulating layer 61 may be epoxy resin, glass epoxy resin, bismaleimide triazine resin, BCB, polyimide, polyamide, polyamideimide, polyurethane, LCP (liquid crystal polymer), PE (polyethylene), PET (polyethylene terephthalate), PFA (perfluoroalkoxy fluororesin), PTFE (polytetrafluoroethylene), ETFE (polymer of tetrafluoroethylene (C2F4) and ethylene (C2H4)), PEEK (polyetheretherketone), parylene resin, solder resist, etc.

[0025] The conductor layer 62 is provided so as to be joined to the outer circumference of the first insulating layer 61. The conductor layer 62 has electrical conductivity. In this embodiment, a plurality of conductor layers 62 are provided along the outer circumference of the first insulating layer 61, on the same circle with gaps in the circumferential direction. One of the plurality of conductor layers 62 corresponds to the first conductor layer, and another conductor layer corresponds to the second conductor layer. The material of the conductor layer 62 may be a metal with high electrical conductivity, such as silver, copper, or gold. The thickness of the conductor layer 62 may be, for example, 0.001 mm to 0.01 mm, or 0.003 mm to 0.005 mm. The conductor layer 62 may be formed so as to be joined to the first insulating layer 61 by plating the outer circumference of the first insulating layer 61 with the metal material that will be the conductor layer 62. The conductor layer 62 may also be joined to the first insulating layer 61 by bonding the conductor layer 62 to the first insulating layer 61 with an adhesive or the like.

[0026] The second insulating layer 63 is provided so as to be bonded to the outer periphery of the conductor layer 62 and to the portion of the outer periphery of the first insulating layer 61 where the conductor layer 62 is not present. The second insulating layer 63 has at least electrical insulating properties. For example, materials that can be used for the second insulating layer 63 may include epoxy resin, glass epoxy resin, bismaleimide triazine resin, BCB, polyimide, polyamide, polyamideimide, polyurethane, LCP (liquid crystal polymer), PE (polyethylene), PET (polyethylene terephthalate), PFA (perfluoroalkoxy fluororesin), PTFE (polytetrafluoroethylene), ETFE (polymer of tetrafluoroethylene (C2F4) and ethylene (C2H4)), PEEK (polyetheretherketone), parylene resin, solder resist, etc.

[0027] The thickness of the layer from the inner circumference of the first insulating layer 61 to the outer circumference of the second insulating layer 63 may be, for example, 0.005 mm to 0.02 mm, or 0.04 mm to 0.06 mm.

[0028] The metal layer 64 is provided so as to be bonded to the outer circumference of the second insulating layer 63. The material of the metal layer 64 may be, for example, silver, copper, nickel, cobalt-nickel alloy, nickel-iron alloy, etc. The thickness of the metal layer 64 may be, for example, 0.001 mm to 0.02 mm, or 0.005 mm to 0.01 mm.

[0029] Figure 4 is a cross-sectional view of the large-diameter portion of the comparative example.

[0030] In this embodiment, the outer diameter of the large diameter portion 11 is 0.35 mm. The diameter of the core shaft 60 is 0.23 mm. The thickness of the layers from the inner circumference of the first insulating layer 61 to the outer circumference of the second insulating layer 63 is 0.05 mm. The thickness of the metal layer 64 is 0.01 mm.

[0031] In contrast, the larger diameter section 101 in the comparative example comprises a core shaft 120, a first insulating layer 121, a conductor layer 62, and a second insulating layer 122. The outer diameter of the larger diameter section 101 is 0.35 mm, the same as that of the larger diameter section 11. The material of the core shaft 120 is the same as that of the core shaft 60. The diameter of the core shaft 120 is 0.25 mm, which is larger than the diameter of the core shaft 60. The materials of the first insulating layer 121 and the second insulating layer 122 are the same as those of the first insulating layer 61 and the second insulating layer 63. The thickness of the layers from the inner circumference of the first insulating layer 121 to the outer circumference of the second insulating layer 122 is 0.05 mm.

[0032] According to the example of the large-diameter section 11 described above, even though the diameter of the core shaft 60 is smaller than the diameter of the core shaft 120 of the large-diameter section 101, it can have approximately 1.3 times the torsional rigidity of the large-diameter section 101 in the comparative example. Therefore, the torque transmission performance of the guide wire can be improved without changing the thickness of the large-diameter section 11. This also means that even if the outer diameter of the large-diameter section 11 is made thinner by further reducing the diameter of the core shaft 60, the same torsional rigidity as the large-diameter section 101 can be obtained.

[0033] According to the guide wire 1 described above, the torsional rigidity of the large-diameter section 11 can be improved, thereby improving torque transmission.

[0034] <Second Embodiment> Figure 5 is a front view of the main body according to the second embodiment. Figure 6 is a cross-sectional view of the large-diameter portion according to the second embodiment. In the guide wire according to the second embodiment, parts similar to those of the guide wire 1 in the first embodiment may be given the same reference numerals and their description may be omitted. In Figure 5, the metal layer 65, which will be described later, is hatched to make it easier to see.

[0035] The guide wire according to the second embodiment includes a main body portion 10A in place of the main body portion 10 of the guide wire 1. The main body portion 10A includes a large diameter portion 11A in place of the large diameter portion 11 of the main body portion 10.

[0036] The larger diameter portion 11A is provided with a metal layer 65 instead of the metal layer 64, and further includes a third insulating layer 66.

[0037] The metal layer 65 is a part of the outer circumference of the second insulating layer 63 and is provided to cover the radially outer side of the gaps between the conductor layers 62 that are arranged on the same circle. The material of the metal layer 65 may be, for example, silver, copper, nickel, cobalt-nickel alloy, nickel-iron alloy, etc. The thickness of the metal layer 65 may be, for example, 0.001 mm to 0.02 mm or 0.005 mm to 0.01 mm. With this metal layer 65, the torsional rigidity can be improved by reinforcing the parts where the torsional rigidity is weak due to the absence of the conductor layers 62.

[0038] The third insulating layer 66 is provided in the portion corresponding to the metal layer 64, where the metal layer 65 is absent. The third insulating layer 66 may be made of the same material as the second insulating layer 63.

[0039] According to the guide wire of the second embodiment, the torsional rigidity of the large-diameter portion 11A can be improved, thereby improving torque transmission.

[0040] <Third Embodiment> Figure 7 is a front view of the main body according to the third embodiment. Figure 8 is a cross-sectional view of the large diameter portion according to the third embodiment. In the guide wire according to the third embodiment, parts similar to those of the guide wire 1 in the first embodiment may be given the same reference numerals and their description may be omitted. In Figure 7, the metal layer 67, which will be described later, is hatched to make it easier to see.

[0041] The guide wire according to the third embodiment includes a main body portion 10B in place of the main body portion 10 of the guide wire 1. The main body portion 10B includes a large diameter portion 11B in place of the large diameter portion 11 of the main body portion 10.

[0042] The larger diameter portion 11B is provided with a metal layer 67 instead of the metal layer 64, and further includes a fourth insulating layer 68.

[0043] The metal layer 67 is provided so as to be joined to a part of the outer circumference of the second insulating layer 63. The material of the metal layer 67 may be, for example, silver, copper, nickel, cobalt-nickel alloy, nickel-iron alloy, etc. The thickness of the metal layer 67 may be, for example, 0.001 mm to 0.02 mm, or 0.005 mm to 0.01 mm. The proportion of the outer circumference of the large diameter portion 11B occupied by the arc in which the metal layer 67 exists may be, for example, 30% or more. In this embodiment, as shown in Figure 7, the metal layer 67 is arranged in a spiral shape on the outer circumference of the large diameter portion 11B. With this metal layer 67, torsional rigidity can be improved compared to the case where no metal layer is provided. Because the metal layer 67 is arranged in a spiral shape, the torsional rigidity in the main body portion 10B can be made relatively uniform.

[0044] The technologies disclosed herein are not limited to the embodiments and modifications described above, and can be modified in various forms without departing from their essence, for example, the following modifications are possible.

[0045] In the above-described embodiment, the large-diameter portion was provided with a metal layer (rigidity-ensuring configuration) extending along its entire longitudinal direction, as shown in Figures 3, 6, and 8. The rigidity-ensuring configuration may be provided only in a portion of the longitudinal direction of the large-diameter portion. The rigidity-ensuring configuration may also be provided in at least a portion of the tapered portion or the small-diameter portion.

[0046] In the above embodiment, multiple conductor layers may be arranged radially in the main body with an insulating layer in between.

[0047] This disclosure is not limited to the configuration of the embodiments described above, but is intended to include all modifications within the meaning and scope of the claims as shown, and equivalents thereof.

Claims

1. Guide wire (1), Core shaft (60) and Sensor (40) and A first insulating layer (61) is provided on the radially outer side of the core shaft (60), A conductive layer (62) is provided on the radially outer side of the first insulating layer (61) and is electrically connected to the sensor (40), A second insulating layer (63) is provided on the radially outer side of the conductor layer (62), A metal layer (64, 65, 67) is provided on the radially outer side of the second insulating layer (63) and is not electrically connected to the conductor layer (62), A guide wire (1) having the following characteristics.

2. The core shaft (60), the first insulating layer (61), the conductor layer (62), the second insulating layer (63), and the metal layers (64, 65, 67) are provided to be integrally formed. The guide wire (1) according to claim 1.

3. The thickness of the aforementioned metal layers (64, 65, 67) is 0.001 mm or more and 0.02 mm or less. A guide wire (1) according to claim 1 or claim 2.

4. The aforementioned conductor layer is a first conductor layer, In cross-section, it further comprises a second conductor layer provided with a gap in the circumferential direction from the first conductor layer, The metal layers (64, 65) are arranged to cover the radially outer side of the gap. A guide wire (1) according to any one of claims 1 to 3.

5. The metal layer (64) is arranged to cover the entire circumference of the core shaft (60) in the cross-section of the guide wire (1). A guide wire (1) according to any one of claims 1 to 4.

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